Setting Up Medical Device Manufacturing in Vietnam: Foreign Investment Guide

Vietnam’s medical device manufacturing sector has emerged as a promising destination for foreign investors, offering a compelling mix of strategic advantages, cost-effectiveness, and growing market opportunities. In 2023, the market was valued at approximately USD 1.67 billion, and it is projected to grow at a compound annual growth rate (CAGR) of 9.9% in USD terms, reaching USD 2.5 billion by 2028 according to BMI. With a rapidly expanding healthcare sector and supportive government policies, Vietnam presents an attractive proposition for medical device manufacturers looking to establish or expand their presence in Southeast Asia. For more market insights, visit the Statista Medical Devices Outlook for Vietnam.

Legal Framework and Requirements

Establishing medical device manufacturing facilities in Vietnam requires careful navigation of various regulatory requirements and procedures. Foreign investors must first obtain an investment registration certificate (IRC) from the Department of Planning and Investment, followed by specific permits related to medical device manufacturing.

Key Regulatory Requirements:

Establishing medical device manufacturing facilities in Vietnam requires adherence to regulatory requirements. Key steps include:

• Investment Registration Certificate (IRC): Obtainable from the Department of Planning and Investment.
• Manufacturing License: Issued by the Ministry of Health’s Department of Medical Equipment and Construction (Decree No. 98/2021/ND-CP, Article 9.1).
• Good Manufacturing Practice (GMP) Certification: Essential for compliance.
• ISO 13485 Certification: Required for quality management systems (Article 9.2 of Decree No. 98/2021/ND-CP).
• Product Registration: Conducted with the Department of Medical Equipment and Health Works (Articles 21, 22, and 29 of Decree No. 98/2021/ND-CP).

In addition, companies must comply with Vietnam’s Law on Investment and the Enterprise Law, which regulate foreign investment activities. For details on medical device registration, visit the U.S. Commercial Service Market Intelligence.

Setting Up Manufacturing Operations

Selecting the right location and establishing proper infrastructure are crucial steps in setting up medical device manufacturing operations in Vietnam.

Location Selection:

• Industrial Zones: Areas near major cities like Hanoi, Ho Chi Minh City, and Da Nang provide excellent infrastructure, tax incentives, and proximity to suppliers and logistics hubs.
• Skilled Labor Accessibility: Regions with a concentrated talent pool for engineering and technical roles can minimize recruitment challenges.
• Local Support Services: Reliable utilities and access to business support services can reduce operational risks.

Infrastructure Requirements: 

While Decree No. 98/2021/ND-CP emphasizes compliance with ISO standards (Article 8.1), businesses should ensure their facilities meet the following requirements:

• Clean Room Facilities: Adhering to international cleanliness standards is critical for device manufacturing.
• Quality Control Laboratories: Essential for product testing and compliance.
• Advanced Storage Solutions: Temperature-controlled warehouses to maintain product integrity.
• Environmentally Compliant Waste Systems: Ensure safe disposal of production waste, in line with environmental regulations.

Investment Incentives and Support

Vietnam’s government actively encourages foreign investment in the medical device sector through the following incentives:

• Corporate Income Tax (CIT) Reductions: Rates as low as 10% for up to 15 years for eligible projects (Articles 13.1 and 14.1, Law on Corporate Income Tax 2014).
• Import Duty Exemptions: Applicable for importing equipment and materials essential for manufacturing (Article 15.1.b, Law on Investment 2020).
• Land Rent Reductions or Exemptions: Available for specific healthcare-related projects (Article 15.1.c, Law on Investment 2020).
• Fast-Track Procedures: Simplified processes for large-scale or strategically important projects (Law on Pharmacy 2016 and Circular No. 08/22/TT-BYT).

These incentives demonstrate the government’s commitment to fostering a conducive environment for healthcare-related investments.

Market Opportunities and Challenges

Key Opportunities

1. Growing Healthcare Spending: Vietnam’s healthcare budget grows by 10-15% annually, underscoring the government’s focus on modernizing medical infrastructure and equipment.
2. Rising Demand for Advanced Devices: Aging demographics and the increasing prevalence of chronic diseases drive demand for innovative medical devices such as diagnostic tools, imaging systems, and surgical equipment.
3. Export Hub Potential: Vietnam’s favorable trade agreements within ASEAN, including reduced tariffs, make it an ideal base for exporting medical devices to regional markets.
4. Infrastructure Expansion: Government-led projects to build hospitals and clinics across the country create ongoing demand for medical devices.

Notable Challenges

1. Complex Regulatory Environment: Frequent updates to regulations require businesses to stay informed and adapt swiftly. Local expertise is invaluable in navigating this landscape.
2. Competition: Both local and international players dominate the market. Companies need innovative products, competitive pricing, and targeted marketing strategies to stand out.
3. Workforce Training: Operating advanced devices necessitates a skilled workforce, which may require significant investment in training and development programs.
4. Intellectual Property Risks: Protecting intellectual property (IP) remains a concern, with instances of counterfeiting and unauthorized duplication posing risks. Robust IP protection strategies are essential.

Conclusion

Vietnam’s medical device manufacturing sector presents significant opportunities for foreign investors, driven by supportive government policies, increasing market demand, and strategic advantages. With the right planning, thorough knowledge of regulatory requirements, and a well-thought-out operational strategy, investors can position themselves for success in this promising market.

For foreign investors, partnering with experienced local consultants and professionals is crucial. They can provide valuable insights, streamline the establishment process, and ensure compliance with Vietnam’s regulatory landscape, paving the way for a smooth market entry. Contact our investment advisory team today for tailored assistance in setting up your medical device manufacturing operations in Vietnam. Let us help you turn opportunities into success. Visit the Ministry of Health’s official website for additional information on regulations and updates. Let us help you turn opportunities into success.

Harley Miller Law Firm “HMLF”

Address: 14th floor, HM Town Building, 412 Nguyen Thi Minh Khai, Ward 05, District 3, Ho Chi Minh City.

Phone: +84 937215585

Website: hmlf.vn

Email: miller@hmlf.vn